510(k) Report

Devices descending from K061553

3 later devices reach Non-Sterile, Powder-Free Black Nitrile Examination Gloves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123116Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)Worldmed Manufacturing Sdn. Bhd.20132—
+2K161099Powder Free Nitrile Examination Gloves, BlackPt. Maja Agung Latexindo20170—
+2K151528Powder Free Nitrile (Black) Examination GlovesGallant Quality Sdn. Bhd.20150—